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Executive Director Of Regulatory Affairs
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Executive Director, Regulatory Affairs (Neurology) – Detailed SummaryLocation: Northern, NJ (Hybrid – 3 days/week onsite)Salary: $270K–$350K + BonusThis senior leadership role is responsible for developing and executing global regulatory strategies for neurology drug programs at a fast-growing, research-driven pharmaceutical company. The Executive Director will lead a team of regulatory professionals across the U.S. and U.K., managing all aspects of regulatory submissions, including INDs, NDAs, BLAs, MAAs, and lifecycle management filings.The ideal candidate will have the following:The main skills needed for this position are the following:•Strategic Initiatives•Health Authority Interactions•Must come from Big Pharma•Been at Associate Director level Position. (12 to 15 yrs of exp)•Innovative Strategies.The role involves direct engagement with global health authorities (FDA, EMA, PMDA), including preparing and leading regulatory meetings, negotiating approval pathways, and ensuring compliance with evolving regulations. The Executive Director will serve as the regulatory lead on product teams, supporting both early and late-stage development, as well as post-approval activities.Success in this role requires at least 12 years of regulatory affairs experience in the biopharma industry, a strong understanding of global regulatory requirements, and a proven track record of managing submissions for major markets. The ideal candidate is a collaborative, strategic thinker with excellent leadership, communication, and decision-making skills.QualificationsBachelor's degree and at least 12 years industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.Education area of study in a scientific discipline with a Master’s or other advanced degree preferred.Position involves line management responsibility for personnel in US and UK and has both direct and indirect reports. Demonstrated success in leading and managing teams is required.Experience in the successful prosecution of NDA/BLA, MAA and supplementary applications in essential.Demonstrated track record of interfacing effectively with FDA, EMA and other global regulatory agencies.Experience in managing the preparation of a marketing application (NDA/BLA/MAA) in CTD format for a major market (US, EU, Canada).PublishStrong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.Excellent operational skills including planning, organizing and ability to motivate and lead others.Excellent verbal and written communication skills and comfortable presenting to all levels of an organization including its Senior Management.Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while maintaining composure an acting with integrity and credibility to build trust.Ability to effectively work with a variety of personnel across a matrix organization and work collaboratively with cross functional teams.Sense of urgency and perseverance to achieve results.Bachelor's degree (Master's preferred) and 10+ years of relevant experience.Experience in Life Sciences industry preferred.
